Delivery of Nebulized Medicines

ABSTRACT

Devices are disclosed that include a positionable elongated member configured to support a delivery tube and maintain a distal end of the tube in a desired position and directional orientation, and to allow the position and orientation of the distal end of the tube to be adjusted by a user. The devices include a multi-segment elongated member configured to support a delivery tube and maintain a distal end of the tube in a desired position and orientation, and a multi-axis joint assembly disposed between segments of the elongated member to allow articulated relative movement of the segments. These devices may be used, for example, in the delivery of vaporized medicine to a patient, e.g., a child or infant on a bed.

BACKGROUND

Devices and methods for delivering nebulized medicines are disclosed inInternational Application PCT/US13/39324, filed May 2, 2013, thecomplete disclosure of which is incorporated herein by reference. Thedevices disclosed therein include a positionable elongated member and adelivery tube, e.g., a length of flexible plastic tubing, disposedwithin the elongated member. Nebulized medicine is delivered through thedelivery tube, and thus it is important that the delivery tube remainfree from kinks or other constrictions regardless of the position of thepositionable elongated member.

SUMMARY

Generally, this invention relates to devices and methods for delivery ofa nebulized medicine to a patient. The devices disclosed herein may beconfigured for use in environments such as patients' homes, hospitals,doctors' offices, and nursing homes. The invention also relates tojoints that may be used in such devices, and in particular to multi-axisjoints that include both pivoting and swiveling functionality. In somecases, the joint can be moved to an open position in which it provides acontinuous open slot for loading tubing into the joint, eliminating theneed to thread tubing through a bore. The invention also features theuse of the multi-axis joints described herein in other applications,particularly applications in which it is necessary to providearticulation while avoiding constriction of tubing disposed within thejoint.

In one aspect, the invention features an apparatus comprising amulti-segment elongated member configured to support a tube and maintaina distal end of the tube in a desired position, and a multi-axis jointassembly disposed between segments of the elongated member to allowarticulated relative movement of the segments.

Some implementations include one or more of the following features.

The multi-axis joint assembly may comprise a pivot joint and a swiveljoint. The elongated member may define an open channel configured toreceive the tube and the swivel joint may be configured to be movedbetween an open position, in which the swivel joint defines a channelthat is colinear with the channel of the elongated member, and a closedposition.

The pivot joint may include a female portion and a male portion havingcorresponding friction faces. The pivot joint may further comprise anadjustment device configured to allow the frictional force between thefriction faces to be adjusted, e.g., a pair of caps that urge thefriction faces together, and adjustment screws configured to adjust thepressure exerted by the caps.

The swivel joint may comprise a hub that is fixed relative to the pivotjoint, and a collar that is rotatably mounted on the hub. In some cases,the hub and collar have corresponding friction faces. The swivel jointmay further comprise an adjustment device configured to allow thefrictional force between the friction faces of the hub and collar to beadjusted, e.g., one or more screws that draw the friction facestogether. In some cases, one of the segments of the elongated member ismounted on the collar.

In some implementations, the multi-axis joint further comprises a secondswivel joint, and the pivot joint is interposed between the two swiveljoints. The hub may be joined to the pivot joint by a keyed engagement.

The apparatus may further include the delivery tube, which may bedisposable, and the elongated member and the multi-axis joint may definea continuous open channel configured to allow the delivery tube to beremoved and replaced. The apparatus may also include a base, on which aproximal end of the elongated member is mounted, and a nozzle at adistal end of the delivery tube.

In some cases, the elongated member includes at least three segments.

The invention also features multi-axis joints having any combination ofthe features disclosed herein.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a device according to one embodiment, inwhich the device includes an articulated arm.

FIG. 1A is a cross-sectional view of an arm of the device shown in FIG.1 with a delivery tube in place.

FIG. 2 is a perspective view of a multi-axis joint assembly according toone implementation.

FIG. 3 is a partially exploded view of the pivot joint portion of themulti-axis joint assembly of FIG. 2.

FIG. 4 is a fully exploded view of the multi-axis joint assembly of FIG.2.

FIGS. 5A and 5B are perspective views of the multi-axis joint assemblyof FIG. 2 with the swivel joint in open (FIG. 5A) and closed (FIG. 5B)positions.

FIG. 6 is a side plan view of the swivel joint portion of the multi-axisjoint assembly. FIG. 6A is a cross-sectional view taken along line A-Ain FIG. 6.

FIG. 7 is an exploded view of the swivel joint.

FIG. 8 is a side plan view of the swivel joint; FIG. 8A is across-sectional view taken along line A-A in FIG. 8; FIG. 8B is aperspective view.

DETAILED DESCRIPTION

Referring to FIG. 1, in one embodiment a nebulized medicine deliverydevice 10 includes a positionable elongated member 12 supported by abase 14. In the embodiment shown in FIG. 1, the positionable elongatedmember 12 includes a first arm 16 which is coupled to the base 14 at itsproximal end 17, and positionably coupled to a second arm 18 by anarticulating joint 20 at its distal end 22. The features of this joint,which is shown diagrammatically in FIG. 1, will be discussed in furtherdetail below with reference to FIGS. 2-7.

As indicated by arrow A, the proximal end 17 of the first arm ispreferably mounted on the base 14 so that it can rotate (arrow A), andin some cases pivot, with respect to the base to enhance the overallpositionability of the device. While rotation is preferred, if desiredthe first arm can be fixedly mounted to the base. In someimplementations, the first arm is mounted on the base as disclosed inU.S. Ser. No. ______, filed ______, Attorney Docket No. 000011-003US1,the full disclosure of which is incorporated herein by reference.

The articulating joint 20 (shown in FIG. 1 for simplicity as a hinge,but which is a multi-axis joint as discussed below) allows the first arm16 and second arm 18 to pivot about the axis of the hinge in the mannerindicated by arrow B.

The device 10 also includes a compressor 40 which delivers compressedgas (e.g., air) to a medicine cup 42 which, when the device is in use,contains a supply of medicine. The medicine cup 42 may be connected tothe first arm 16 (as shown), or mounted within the arm or base, e.g., asdisclosed in U.S. Ser. No. ______, filed ______, Attorney Docket No.000011-003US1, so as to hold the medicine cup in a stable, substantiallyvertical position during delivery of the medicine. This stablepositioning of the medicine cup facilitates use of the device andenhances the effectiveness of the nebulizer. The compressor is connectedto a power supply (not shown).

Medicine is nebulized in the medicine cup and then delivered to thepatient via a delivery tube 44. As shown in detail in FIG. 1A, thedelivery tube 44 is disposed in a channel 46 in the first arm 16. Thesecond arm 18 includes a similar channel (not shown). These channelsallow the tube to be held securely but removably within the positionableelongated member 12. Because the delivery tube is removable from thechannel it can be easily replaced.

A nozzle 24 is mounted at the distal end 26 of the second arm, or to thedistal end of the delivery tube, for delivery of the vaporized medicineto an area adjacent the patient's face. For example, delivery can bedirected toward the patient's nose and mouth, so that the patient willreceive the medicine regardless of whether she is breathing through hermouth or nose. Mounting of the nozzle may be by a pivotable connection28, as shown, to provide fluid communication between the nozzle 24 andthe delivery tube 44 while allowing the position of the nozzle to befinely adjusted as indicated by arrows C. Preferred types of nozzles aredisclosed in International Application PCT/US13/39324, incorporated byreference above.

Referring now to FIG. 2, the joint 20 is a multi-axis joint, whichprovides both a pivoting articulation, via pivot joint 50, and aswiveling motion, via swivel joint 52. The pivoting articulation isabout an axis that is generally perpendicular to the long axis of thedelivery tube, while the swiveling motion is about an axis that isgenerally parallel to the long axis of the delivery tube. The degree offriction (and conversely the ease of motion) of these joints areprovided by a pivot joint adjustment screws 54 and a swivel jointadjustment screws 56, as will be discussed in further detail below.

The components of the pivot joint 50 are shown in more detail in FIG. 3.Pivot joint 50 includes a female portion 58 and a male portion 60. Themale portion 60 is received between the two extending members 62 a, 62 bof the female portion, such that inner friction faces 64 a, 64 b of thefemale portion are in contact with adjacent friction faces 66 a, 66 b ofthe male portion. Outer friction faces 68 a and 68 b of the extendingmembers contact friction surfaces 70 a, 70 b of a pair of pivot jointcaps 72 a, 72 b. Each of the pivot caps includes a no-slip hex lock 74 aand 74 b (not shown), which, when the joint is assembled, extend throughbores 76 a, 76 b in the extending members and are received intohexagonal openings 78 a (not shown) and 78 b in the male portion 60. Theentire assembly is held together by a plurality of pivot jointadjustment screws 54. Screws 54 are received in threaded openings 80 inthe pivot joint caps, through slots 82 in the extending members 62 a, 62b, and into threaded openings 84 in the male portion. The extent towhich the screws are tightened will determine the frictional forcebetween the various friction faces, and thus how easily the femaleportion can pivot with respect to the male portion. Thus, the freedom ofmovement of the pivot joint can be easily adjusted both duringmanufacturing and by the end user simply by loosening or tightening thescrews.

As can be seen in FIG. 5A, in preferred implementations both the femaleand male portions of the pivot joint define an open channel, i.e., thenare semi-cylindrical rather than cylindrical in shape. This featurefacilitates easy insertion and removal of the delivery tube, allowingthe end user to readily change out this disposable portion of thedevice.

The components of swivel joint 52 are shown in detail in FIGS. 4-7. Theswivel joint performs two functions: (1) it provides a swivelingmovement to the elongated member, about an axis generally parallel tothe long axis of the delivery tube, as discussed above, and (2) itincludes a portion that can be swiveled between an open position, inwhich the swivel joint defines an open channel that is colinear withthat defined by the pivot joint (FIG. 5A), and a closed position (FIG.5B). In some cases, in the closed position the swivel joint defines aclosed cylinder.

The first function is particularly helpful when the elongated member ofthe delivery device includes more than one joint 20. If a plurality ofjoints are provided, then the swiveling function allows each segment ofthe elongated member to swivel relative to the adjacent segment, greatlyincreasing the degrees of freedom of the device. The second functionallows the delivery tube to be easily inserted and removed from theswivel joint.

Referring to FIGS. 4 and 7, the swivel joint includes a swivel joint hub90 and a swivel joint collar 92. The swivel joint hub 90 includes aplurality of teeth 94 at one end, which are configured for keyedengagement with corresponding openings in the end surface of the maleportion of the pivot joint. (These openings, not shown, are similar toopenings 96 in face 98 of the female portion, as shown in FIGS. 5A-5B.)

An elongated member 93 is fixedly attached to the swivel joint collar,e.g., by screws 91 extending through through-holes 99 (FIG. 7) in theswivel joint collar 92 and into corresponding threaded openings 97 (FIG.4) in the elongated member.

Because of its keyed attachment to the male portion of the pivot joint,the swivel joint hub 90 is fixed relative to the pivot joint. The swiveljoint collar 92 is positioned on the swivel joint hub for rotationrelative to the swivel joint hub 90, thus allowing the elongated member93 to swivel relative to the pivot joint. The freedom of rotation isdetermined by adjusting the normal force between friction face 98 of theswivel joint hub and friction face 100 of the swivel joint collar (bestseen in FIG. 7), resulting in increased or decreased friction. Thefrictional force is adjusted by loosening or tightening screws 56 whichextend through screw bosses 102 and draw the swivel joint hub toward thepivot joint (see arrow in FIG. 6A) thereby generating frictional forceat the frictional interface (FIG. 6A) between the two friction faces.

Referring to FIG. 8, the swivel joint may include features that limitits rotation and/or serve to prevent the hub from coming out of thecollar when the swivel joint is in its open position.

To limit rotation, e.g., to about 135 degrees or less, in someimplementations a rotation stop tab 100 is provided on the swivel jointhub 90. This tab interferes with one of a pair of collar stop limitfeatures 102 on the swivel joint collar at the desired limit of rotationin each direction.

To prevent separation of the hub from the collar the cylindrical bore ofthe hub 101 and the cylindrical shaft 102 have surfaces that comprisemore than 180° of contacting surface. This surface acts to retain thecollar and hub together in all positions as the joint rotates.

If desired, a second swivel joint (not shown) can be provided forattachment to the female portion of the pivot joint, using the openings96, in which case a second elongated member would be fixedly attached tothe swivel joint hub of the second swivel joint. Alternatively, ifswiveling motion is not desired between the female portion of the pivotjoint and the attached elongated member, the elongated member can befixedly attached directly to the female member.

OTHER EMBODIMENTS

A number of embodiments have been described. Nevertheless, it will beunderstood that various modifications may be made without departing fromthe spirit and scope of the disclosure.

For example, while it is generally preferable to combine the pivotingand swiveling features described above in a single multi-axis joint, insome cases these features may be used individually, to provide a pivotjoint or a swivel joint.

Moreover, while the multi-axis joint has been discussed above in thecontext of its use in the delivery of nebulized medicines, themulti-axis joint may be used in a variety of other applications, such asin other medical devices where multi-axis movement would be useful,particularly where it is important to be able to remove and replacetubing that runs through the joint. The multi-axis joint could also beused in other applications in which a precise and flexible positioningand directional control of delivery of a gas or fluid is desired, e.g.,in industrial applications such as painting or welding.

Additionally, in some implementations, for example in applications notrequiring an open channel for insertion of tubing, the joint couldinclude cylindrical members rather than members that are shaped todefine an open channel.

Accordingly, other embodiments are within the scope of the followingclaims.

What is claimed is:
 1. An apparatus comprising: a multi-segmentelongated member configured to support a tube and maintain a distal endof the tube in a desired position, and a multi-axis joint assemblydisposed between segments of the elongated member to allow articulatedrelative movement of the segments.
 2. The apparatus of claim 1 whereinthe multi-axis joint assembly comprises a pivot joint and a swiveljoint.
 3. The apparatus of claim 2 wherein the elongated member definesan open channel configured to receive the tube and the swivel joint ismoved between an open position in which the swivel joint defines achannel that is colinear with the channel of the elongated member, and aclosed position.
 4. The apparatus of claim 1 wherein the pivot jointcomprises a female portion and a male portion having correspondingfriction faces.
 5. The apparatus of claim 4 wherein the pivot jointfurther comprises an adjustment device configured to allow thefrictional force between the friction faces to be adjusted.
 6. Theapparatus of claim 5 wherein the adjustment device comprises a pair ofcaps that urge the friction faces together, and adjustment screwsconfigured to adjust the pressure exerted by the caps.
 7. The apparatusof claim 2 wherein the swivel joint comprises a hub that is fixedrelative to the pivot joint, and a collar that is rotatably mounted onthe hub.
 8. The apparatus of claim 7 wherein the hub and collar havecorresponding friction faces.
 9. The apparatus of claim 8 wherein theswivel joint further comprises an adjustment device configured to allowthe frictional force between the friction faces of the hub and collar tobe adjusted.
 10. The apparatus of claim 9 wherein the adjustment devicecomprises one or more screws that draw the friction faces together. 11.The apparatus of claim 7 wherein one of the segments of the elongatedmember is mounted on the collar.
 12. The apparatus of claim 2 whereinthe multi-axis joint further comprises a second swivel joint, and thepivot joint is interposed between the two swivel joints.
 13. Theapparatus of claim 7 wherein the hub is joined to the pivot joint by akeyed engagement.
 14. The apparatus of claim 1 further comprising thetube.
 15. The apparatus of claim 14 wherein the tube comprises adisposable delivery tube.
 16. The apparatus of claim 15 wherein theelongated member and the multi-axis joint define a continuous openchannel configured to allow the delivery tube to be removed andreplaced.
 17. The apparatus of claim 1 wherein the elongated memberincludes at least three segments.
 18. The apparatus of claim 1 furthercomprising a base on which a proximal end of the elongated member ismounted.
 19. The apparatus of claim 15 further comprising a nozzleprovided at a distal end of the delivery tube.